Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Approves New Device to Counteract Overdoses (4 April 2014)

Regulatory Reconnaissance: FDA Approves New Device to Counteract Overdoses (4 April 2014)

Posted 04 April 2014 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • FDA Approves New Hand-Held Auto-Injector to Reverse Opioid Overdose (FDA) (SCRIP-$) (PMLive) (Press) (BioCentury) (Reuters) (NYTimes) (MedPage Today) (AP) (NBC) (WaPo) (WSJ-$) (Pink Sheet-$) (Forbes) (SciAm) (Law 360-$) (FDA) (FDA)
  • U.S. FDA Ups China Drug Inspections Amid Global Supply-Chain Concerns (Reuters) (Bloomberg)
  • Mylan sues Celgene Over Use of REMS Plans to Block Generics of Revlimid, Thalomid (Reuters)
  • Vermont Restricting Access to Powerful Painkillers (AP)
  • FDA Allows Marketing for First-of-Kind Dressing to Control Bleeding From Certain Battlefield Wounds  (FDA)
  • Public Citizen to FDA: Take Enforcement Against Companies Manufacturing and Distributing Misbranded Medical Devices (Public Citizen)
  • St. Jude's Upgradeable Spinal Cord Stimulation System Receives FDA Approval (Press)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • FDA approves new hand-held auto-injector to reverse opioid overdose (FDA) (SCRIP-$) (PMLive) (Press) (BioCentury) (Reuters) (NYTimes) (MedPage Today) (AP) (NBC) (WaPo) (WSJ-$) (Pink Sheet-$) (Forbes) (SciAm) (Law 360-$) (FDA) (FDA)
  • U.S. FDA ups China drug inspections amid global supply-chain concerns (Reuters) (Bloomberg)
  • Mylan sues Celgene Over Use of REMS Plans to Block Generics of Revlimid, Thalomid (Reuters)
  • Vermont Restricting Access to Powerful Painkillers (AP)
  • Post-Marketing Commitments: FDA's Revised Metric Paints Bleaker Picture (Pink Sheet-$)
  • The More Things Change, The More They Remain The Same: FDA's Consultations of Trial Lawyers (D&D Law)
  • CBER FY 2013 Recall Statistics (CBER)
  • Reinventing OTCs: FDA Seeks New Models; Stakeholders Urge Renewed Focus (RPM Report-$)
  • Arkansas to Ask Court to Reconsider Drug Fine (AP)
  • Dyax Receives FDA Approval to Expand Use of KALBITOR (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema to Patients 12 Years of Age and Older (Press)
  • MassBio panel tackles drug industry's bad reputation (BioFlash)
  • Halozyme temporarily halts pancreatic cancer study (Reuters) (Press) (Fierce)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Santen Phase III Study Meets Primary Endpoint for the Treatment of Non-Infectious Posterior Segment Uveitis (NI-PSU) (Press)
  • Amgen Provides Update On Phase 3 Study Of Talimogene Laherparepvec In Patients With Metastatic Melanoma (Press)
  • Critical Outcome Submits Orphan Drug Application For COTI-2 (Press)

US: Pharmaceuticals and Biotechnology: General

  • Drug Firms Divided On Allowing Copay Coupons In Exchange Plans (Pink Sheet-$)
  • Supreme Court to Decide Texas Execution Drug Case (PharmPro)
  • Texas: Serial Killer Executed With New Dose of Drug (NYTimes)
  • ProPublica Goes After The Wrong Man In Its 'Dollars For Docs' Crusade (Forbes)

US: Medical Devices

  • FDA allows marketing for first-of-kind dressing to control bleeding from certain battlefield wounds  (FDA)
  • Public Citizen to FDA: Take Enforcement Against Companies Manufacturing and Distributing Misbranded Medical Devices (Public Citizen)
  • Deny Approval For Products Lacking Good Subgroup Data, Patient, Medical Groups Tell FDA (Gray Sheet-$)
  • St. Jude's Upgradeable Spinal Cord Stimulation System Receives FDA Approval (Press)
  • Escalon Medical Corp. Receives FDA 510(k) Clearance for the Sonomed Escalon VuPad (Press)
  • Health app users, beware (USA Today)

US: Dietary Supplements

  • NEJM Article Calls for DSHEA Overhaul, Industry for Serious Enforcement (NPI)
  • Industry experts dispute dietary supplement critic Cohen's call for sweeping new regulations (NI-USA)

US: Assorted And Government

  • FDA Recruiting for Top Spots (FDA)

Europe

India

  • India Drug Firms Look Abroad For Trials, Government Tries To Trim Delays (PharmAsia-$)
  • AstraZeneca hauls Glenmark to Indian court over saxagliptin (SCRIP-$)

Japan & China

  • AdvaMed Works With China On UDI System Using Global Framework (IHP-$)
  • GlaxoSmithKline sacks some China staff for malpractice: source (Reuters) (Bloomberg)
  • Novartis replaces top management in Japan after probe on clinical trials (Reuters)

Other International

  • TGA Joins Other Regulators, Warns About Dangers of HES Starch (TGA)
  • New law in Brazil changes enforcement of BGMP requirements for certain medical devices (Mass Device)

General Regulatory And Interesting Articles

  • My sister, and life science's limits (Fierce)
  • I had my DNA analyzed, and all I got was this lousy story (Ars Technica)

Regulatory Reconnaissance #291 - 4 April 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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